Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K123868 |
Device Name |
INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET |
Applicant |
BAXTER HEALTHCARE CORP. |
32650 N WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Applicant Contact |
GARY CHUMBIMUNE |
Correspondent |
BAXTER HEALTHCARE CORP. |
32650 N WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Correspondent Contact |
GARY CHUMBIMUNE |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 12/17/2012 |
Decision Date | 01/08/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|